DK1633327T3 - Process for improving stability and storage life of liposome complexes - Google Patents

Process for improving stability and storage life of liposome complexes

Info

Publication number
DK1633327T3
DK1633327T3 DK04754323.6T DK04754323T DK1633327T3 DK 1633327 T3 DK1633327 T3 DK 1633327T3 DK 04754323 T DK04754323 T DK 04754323T DK 1633327 T3 DK1633327 T3 DK 1633327T3
Authority
DK
Denmark
Prior art keywords
storage life
improving stability
liposome complexes
complex
solution
Prior art date
Application number
DK04754323.6T
Other languages
Danish (da)
Inventor
Esther H Chang
Kathleen F Pirollo
Original Assignee
Univ Georgetown
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Univ Georgetown filed Critical Univ Georgetown
Application granted granted Critical
Publication of DK1633327T3 publication Critical patent/DK1633327T3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6849—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6905—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a colloid or an emulsion
    • A61K47/6911—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a colloid or an emulsion the form being a liposome
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6905—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a colloid or an emulsion
    • A61K47/6911—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a colloid or an emulsion the form being a liposome
    • A61K47/6913—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a colloid or an emulsion the form being a liposome the liposome being modified on its surface by an antibody
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/005—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'active' part of the composition delivered, i.e. the nucleic acid delivered
    • A61K48/0058—Nucleic acids adapted for tissue specific expression, e.g. having tissue specific promoters as part of a contruct
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/0002—General or multifunctional contrast agents, e.g. chelated agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
    • A61K9/1272—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers with substantial amounts of non-phosphatidyl, i.e. non-acylglycerophosphate, surfactants as bilayer-forming substances, e.g. cationic lipids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A61K9/1277—Processes for preparing; Proliposomes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/87—Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation
    • C12N15/88—Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation using microencapsulation, e.g. using amphiphile liposome vesicle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dispersion Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Plant Pathology (AREA)
  • Dermatology (AREA)
  • Cell Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Physics & Mathematics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

A method for preparing a stable cell-targeting complex comprising a ligand and a cationic liposome encapsulating a therapeutic or diagnostic agent comprises (a) combining the complex with a solution comprising a stabilizing amount of sucrose and (b) lyophilizing the resultant solution to obtain a lyophilized preparation; wherein, upon reconstitution, the preparation retains at least about 80% of its pre-lyophilization activity.
DK04754323.6T 2003-06-04 2004-06-04 Process for improving stability and storage life of liposome complexes DK1633327T3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US47550003P 2003-06-04 2003-06-04
PCT/US2004/017695 WO2005000271A1 (en) 2003-06-04 2004-06-04 Method for improving stability and shelf-life of liposome complexes

Publications (1)

Publication Number Publication Date
DK1633327T3 true DK1633327T3 (en) 2010-11-15

Family

ID=33551542

Family Applications (1)

Application Number Title Priority Date Filing Date
DK04754323.6T DK1633327T3 (en) 2003-06-04 2004-06-04 Process for improving stability and storage life of liposome complexes

Country Status (14)

Country Link
US (1) US20050002998A1 (en)
EP (1) EP1633327B1 (en)
JP (2) JP4987474B2 (en)
CN (2) CN1798545B (en)
AT (1) ATE476964T1 (en)
AU (1) AU2004251680B2 (en)
CA (1) CA2528411C (en)
DE (1) DE602004028610D1 (en)
DK (1) DK1633327T3 (en)
ES (1) ES2350485T3 (en)
HK (2) HK1086202A1 (en)
PL (1) PL1633327T3 (en)
PT (1) PT1633327E (en)
WO (1) WO2005000271A1 (en)

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US8617514B2 (en) 1999-02-22 2013-12-31 Georgetown University Tumor-targeted nanodelivery systems to improve early MRI detection of cancer
JP4571514B2 (en) * 2005-01-21 2010-10-27 ポーラ化成工業株式会社 Vesicle external composition
AU2006242354B2 (en) * 2005-04-29 2012-03-15 University Of Louisville Research Foundation, Inc. Cell-surface decoration with active agents
CA2638899C (en) * 2005-10-20 2016-01-05 Georgetown University Tumor-targeted nanodelivery systems to improve early mri detection of cancer
EP2023897A4 (en) * 2006-05-15 2013-04-03 Univ Georgetown Preparation of antibody or an antibody fragment-targeted immunoliposomes for systemic administration of therapeutic or diagnostic agents and uses thereof
EP2022853A4 (en) * 2006-05-17 2010-03-10 Yoshiyuki Koyama Freeze-dried product for transferring nucleic acid, oligonucleic acid or derivative thereof
CN105343932A (en) 2007-01-30 2016-02-24 匹兹堡大学 Bioerodible wraps and uses therefor
JP5890095B2 (en) 2007-07-09 2016-03-22 ジョージタウン・ユニバーシティＧｅｏｒｇｅｔｏｗｎ Ｕｎｉｖｅｒｓｉｔｙ Methods of eliciting an immune response using cationic liposome-mediated nucleic acid delivery
CN101485629B (en) * 2008-01-16 2013-01-23 沈阳药科大学 Drug delivery system and preparation method thereof
US10143652B2 (en) 2009-09-23 2018-12-04 Curirx Inc. Methods for the preparation of liposomes
EP2480208A1 (en) 2009-09-23 2012-08-01 Indu Javeri Methods for the preparation of liposomes
AU2010315417B2 (en) 2009-10-28 2016-12-15 Neograft Technologies, Inc. Bioerodible wraps and uses therefor
EP2519188A4 (en) 2009-12-31 2017-03-22 Neograft Technologies, Inc. Graft devices and methods of fabrication
CA2795765C (en) 2010-04-06 2020-07-07 Fred Hutchinson Cancer Research Center Methods for identifying and using inhibitors of casein kinase 1 epsilon isoform for inhibiting the growth and/or proliferation of myc-driven tumor cells
EP2595695B1 (en) 2010-07-19 2019-02-06 Neograft Technologies, Inc. Graft devices and methods of use
WO2013016349A2 (en) 2011-07-25 2013-01-31 Neograft Technologies, Inc. Vessel treatment methods and devices for use in a graft device
JP2014062084A (en) 2012-09-19 2014-04-10 Georgetown Univ Targeted liposomes
US20140120157A1 (en) 2012-09-19 2014-05-01 Georgetown University Targeted liposomes
CN105163762B (en) 2013-03-14 2019-06-25 乔治敦大学 Treatment to the exposure of never poison
WO2015077602A1 (en) 2013-11-22 2015-05-28 Fred Hutchinson Cancer Research Center Methods for identifying therapeutic targets and treating and monitoring cancers
WO2016090183A1 (en) * 2014-12-03 2016-06-09 Capricor Therapeutics, Inc. Processes for producing stable exosome formulations
LT3324932T (en) * 2015-07-22 2021-04-26 Nitto Denko Corporation Compositions and methods for nanoparticle lyophile forms
WO2017192863A1 (en) 2016-05-04 2017-11-09 L.E.A.F. Holdings Group Llc Targeted liposomal gemcitabine compositions and methods thereof
WO2018026794A1 (en) * 2016-08-02 2018-02-08 Curirx Inc. Methods for the preparation of liposomes
CN114392233A (en) 2017-10-20 2022-04-26 生物技术公司 Preparation and storage of liposomal RNA formulations suitable for therapeutic use

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JPH01106829A (en) * 1987-10-21 1989-04-24 Tosoh Corp Method for lyophilizing superoxide dismutase-retaining liposome pharmaceutical
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US5811406A (en) * 1995-06-07 1998-09-22 Regents Of The University Of California Dry powder formulations of polynucleotide complexes
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Also Published As

Publication number Publication date
DE602004028610D1 (en) 2010-09-23
EP1633327B1 (en) 2010-08-11
WO2005000271A1 (en) 2005-01-06
EP1633327A4 (en) 2009-03-04
ES2350485T3 (en) 2011-01-24
AU2004251680A1 (en) 2005-01-06
JP4987474B2 (en) 2012-07-25
PL1633327T3 (en) 2011-02-28
CN103251562A (en) 2013-08-21
JP2012121885A (en) 2012-06-28
CA2528411A1 (en) 2005-01-06
ATE476964T1 (en) 2010-08-15
JP2006526658A (en) 2006-11-24
CN1798545B (en) 2013-06-05
CA2528411C (en) 2012-09-04
AU2004251680B2 (en) 2010-02-18
HK1086202A1 (en) 2006-09-15
CN1798545A (en) 2006-07-05
PT1633327E (en) 2010-11-08
US20050002998A1 (en) 2005-01-06
HK1188147A1 (en) 2014-04-25
EP1633327A1 (en) 2006-03-15
CN103251562B (en) 2016-04-27

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